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PubMed2006

Short communication: treatment of relapsing-remitting multiple sclerosis 96 patients with IFN-beta 1b: results of a 6-year follow-up.

The first pharmacon with proved efficacy for the treatment of patients with the relapsing-remitting or relapsing-progressive form of multiple sclerosis (MS) was interferon-beta1b (IFN-beta1b). In 1996, we started treating 34 relapsing-remitting (RRMS) and 2 relapsing-progressive MS (RPMS) patients with IFN-beta1b. Of these 36 patients, 28 received continuous medication for 6 years. The primary end point of the study was the effect of 6 years of continuous IFN-beta1b treatment on the annual relapse rate, the secondary end point was the change in the progression index during the 6 years, and the tertiary end point was the alteration in the expanded disability status scale (EDSS) score of the patients. Finally, we give the reasons for the dropouts. The relapse rate decreased by 80.62% (p < 0.001), the mean EDSS score increased significantly, by approximately 0.5 points, to 2.21 +/- 1.48 (p = 0.016), and the reduction in the mean progression index was 67.19% (p < 0.001). This increase of < 0.5 point in the EDSS score is appreciably different from the 3-point deterioration expected after 6 years for the natural course of the disease. The significant improvement in the progression index clearly demonstrates that 6 years of IFN-beta1b therapy slowed the progression of the disease, thereby improving the quality of life of these MS patients.

Adult↗

PubMed2003

A double-blind, randomized, placebo-controlled trial of olanzapine in the prevention of psychotic relapse.

Sustained response to antipsychotic therapy is an important outcome measure for patients with psychotic disorders. Placebo control in studies of relapse prevention contributes valuable information yet provokes much debate. This study, using placebo as a control, evaluated olanzapine's efficacy in preventing a psychotic relapse. Participants were stable minimally symptomatic outpatients with schizophrenia or schizoaffective disorder. The study included 4 phases: (1) 4-day to 9-day screening/evaluation (N = 583), (2) 6-week conversion to open-label olanzapine (N = 493; 10-20 mg/d), (3) 8-week stabilization on olanzapine (N = 458; 10-20 mg/d), and (4) 52-week randomized (2:1), double-blind maintenance with olanzapine (N = 224; 10-20 mg/d) or placebo (N = 102). Primary relapse criteria were clinically significant changes in the Brief Psychiatric Rating Scale (BPRS) positive item cluster or rehospitalization due to positive symptoms. Statistical methodology allowed sequential real-time estimation of efficacy across blinded treatment groups and multiple interim analyses, which permitted study termination when efficacy was significantly different between treatments. A significant between-treatment difference emerged 210 days after first patient randomization to double-blind treatment. Thus, 151 (46.3%) of the randomized patients were discontinued early and 34 (10.4%) of the planned patient enrollment were not required. The olanzapine group had a significantly longer time to relapse (P < 0.0001) than the placebo group. The 6-month cumulative estimated relapse rate (Kaplan-Meier) was 5.5% for olanzapine-treated patients versus 55.2% for placebo-treated patients. The design of this study enabled appropriate statistical testing of the primary hypothesis while minimizing exposure of patients to a less effective treatment than olanzapine. In remitted stabilized patients with schizophrenia or schizoaffective disorder, olanzapine demonstrated a positive benefit-to-risk profile in relapse prevention.

Adolescent↗

PubMed2004

The relapse rate of multiple sclerosis changes during pregnancy: a cohort study.

OBJECTIVE: To evaluate the influence of pregnancy and puerperium on the relapse rate of multiple sclerosis (MS). METHODS: We determined retrospectively the yearly mean relapse rate (MRR) during pregnancies occurring in the course of relapsing-remitting MS. We compared the MRR of pregnancy-time with that of non-pregnancy time by paired t-test. Relative risk (RR) of relapses during the pregnancy-time was also compared with that of non-pregnancy time by chi(2) analysis and 95% confidence intervals. RESULTS: From a population of 351 women affected by clinically definite MS, only 70 reported pregnancies during their relapsing-remitting phase of MS for a total of 98 pregnancies. Both MRR (P = 0.006) and RR (RR = 0.63, 95% CI = 0.40-0.94) decreased during the three trimesters of pregnancy. RR increased in the first 3 months of puerperium, although this was not statistically significant (RR = 1.36, 95% CI = 0.79-2.20). CONCLUSION: Our study confirms that in MS the relapse rate decreases throughout pregnancy and increases during puerperium. This suggests a complex interplay between hormonal and immune factors.

Adolescent↗

PubMed2006

Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.

OBJECTIVES: To compare the relative efficacies of Betaferon, Avonex, and Rebif in the treatment of relapsing-remitting multiple sclerosis (RRMS). METHODS: Ninety patients with RRMS were randomly allocated to the three treatment groups. The first group received Betaferon, the second group received Avonex, and the third group received Rebif for 24 months. Response to treatment was assessed at 6, 12, and 24 months after start of therapy. RESULTS: Of the 30 patients treated with Betaferon, the mean (standard deviation, SD) of relapse rate decreased from 2.2 (0.7) to 0.7 (0.7) episodes. Correspondingly, in the 30 patients treated with Avonex, the mean (SD) of relapse rate decreased from 2.0 (1.2) to 1.2 (0.9) (P < 0.001). In the 30 patients treated with Rebif, the mean (SD) of relapse rate decreased from 2.4 (1.0) to 0.6 (0.9) (P < 0. 01). After 2 years, 43.3% of patients receiving Betaferon and 56.7% of patients receiving Rebif remained relapse-free compared with 20% of those given Avonex. Expanded Disability Status Scale (EDSS) decreased by 0.7 U in Betaferon-treated patients (P < 0.001), 0.3 U in Rebif-treated patients (P < 0.05), and remained stable in Avonex patients. CONCLUSION: Treatment with Betaferon, Avenox, and Rebif significantly reduce relapse rate and EDSS score in patients with RRMS.

Adjuvants, Immunologic↗

PubMed2006

Relapsing fever spirochetes Borrelia recurrentis and B. duttonii acquire complement regulators C4b-binding protein and factor H.

Relapsing fever is a rapidly progressive and severe septic disease caused by certain Borrelia spirochetes. The disease is divided into two forms, i.e., epidemic relapsing fever, caused by Borrelia recurrentis and transmitted by lice, and the endemic form, caused by several Borrelia species, such as B. duttonii, and transmitted by soft-bodied ticks. The spirochetes enter the bloodstream by the vector bite and live persistently in plasma even after the development of specific antibodies. This leads to fever relapses and high mortality and clearly indicates that the Borrelia organisms utilize effective immune evasion strategies. In this study, we show that the epidemic relapsing fever pathogen B. recurrentis and an endemic relapsing fever pathogen, B. duttonii, are serum resistant, i.e., resistant to complement in vitro. They acquire the host alternative complement pathway regulator factor H on their surfaces in a similar way to that of the less serum-resistant Lyme disease pathogen, B. burgdorferi sensu stricto. More importantly, the relapsing fever spirochetes specifically bind host C4b-binding protein, a major regulator of the antibody-mediated classical complement pathway. Both complement regulators retained their functional activities when bound to the surfaces of the spirochetes. In conclusion, this is the first report of complement evasion by Borrelia recurrentis and B. duttonii and the first report showing capture of C4b-binding protein by spirochetes.

Borrelia↗

PubMed1996

GlpQ: an antigen for serological discrimination between relapsing fever and Lyme borreliosis.

Tick-borne relapsing fever is caused by numerous Borrelia species maintained in nature by Ornithodoros tick-mammal cycles. Serological confirmation is based on either an immunofluorescence assay or an enzyme-linked immunosorbent assay using whole cells or sonicated Borrelia hermsii as the antigen. However, antigenic variability of this bacterium's outer surface proteins and antigens shared with the Lyme disease spirochete (B. burgdorferi), may cause both false-negative and false-positive results when testing sera of patients suspected to have either relapsing fever or Lyme disease. To develop a specific serological test for relapsing fever, we created a genomic DNA library of B. hermsii, screened transformed Escherichia coli cells for immunoreactivity with high-titered (> or = 1:2,048) human anti-B. hermsii antiserum, and selected an immunoreactive clone (pSPR75) expressing a 39-kDa protein. DNA sequencing, subcloning, and serum adsorption experiments identified the immunoreactive protein as a homolog of GlpQ, a glycerophosphodiester phosphodiesterase identified previously in E. coli, Haemophilus influenzae, and Bacillus subtilis. Serum samples from humans and mice infected with B. hermsii or other species of relapsing fever spirochetes contained antibodies recognizing GlpQ, whereas serum samples from Lyme disease and syphilis patients were nonreactive. Serologic tests based on this antigen will identify people exposed previously to relapsing fever spirochetes and help clarify the distribution of relapsing fever and Lyme disease in situations in which the occurrence of their causative agents is uncertain.

Amino Acid Sequence↗

PubMed2006

Serum matrix metalloproteinase-3 levels correlate with disease activity in relapsing-remitting multiple sclerosis.

BACKGROUND: Adhesion molecules and matrix metalloproteinases (MMPs) are known to be relevant to the ongoing development and disappearance of areas of demyelination in the white matter of the CNS of multiple sclerosis (MS) patients. This study examined whether serum matrix metalloproteinase-3 (MMP-3) levels correlate with disease activity in MS. METHODS: Serum MMP-3 levels in 47 consecutive patients with relapsing-remitting MS were measured by immunoassay every 4 weeks over a 15 month period. RESULTS: During the study period, 48 clinical relapses occurred. Serum MMP-3 levels within 1 month of relapse were significantly higher than during the remission phase. Sequential analysis showed that serum MMP-3 levels had increased transiently at the time of clinical relapse but returned to the normal range within a month. CONCLUSIONS: Circulatory MMP-3 levels are correlated with disease activity in relapsing-remitting MS. This may contribute to the breakdown of the blood-brain barrier at the time of relapse.

Adult↗

PubMed2000

Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Sclerosis Study Group.

In a randomized, placebo-controlled, double-blind study, glatiramer acetate (Copaxone) reduced the relapse rate and slowed accumulation of disability for patients with relapsing - remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug. The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse. The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months. Daily subcutaneous injections of 20 mg glatiramer acetate were well tolerated. The mean annual relapse rate of the patients who received glatiramer acetate since randomization and continued into the open-label study was 0.42 (95% confidence interval (CI), CI=0.34 - 0.51). The rate per year has continued to drop and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one step on the Expanded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded, providing information about their current status and reasons for dropping out. This study demonstrates the sustained efficacy of glatiramer acetate in reducing the relapse rate and in slowing the accumulation of disability in patients with relapsing forms of multiple sclerosis. Multiple Sclerosis (2000) 6 255 - 266

Adjuvants, Immunologic↗

PubMed2005

Randomized study of once-weekly interferon beta-1la therapy in relapsing multiple sclerosis: three-year data from the OWIMS study.

BACKGROUND: Once weekly interferon beta-1a for multiple sclerosis (OWIMS) demonstrated modest, but significant, magnetic resonance imaging (MRI) benefit of once-weekly (qw) interferon (IFN) beta-1a at 48 weeks, but no significant effect on relapses. OBJECTIVE: An OWIMS extension permitted assessment of longer-term efficacy/safety of qw IFN beta-1a in relapsing-remitting multiple sclerosis (RRMS). METHODS: Placebo patients were rerandomized to IFN beta-1a, 22 or 44 mcg qw, for two additional 48-week intervals. Primary outcome was MRI lesion activity. Relapse rate and other MRI measures were secondary outcomes. RESULTS: After three years, median (mean) T2 lesion count/patient/scan was 1.3 (2.6) for 44 mcg, 1.7 (3.3) for 22 mcg, 1.7 (3.4) for placebo/22 mcg, 2.0 (3.6) for placebo/44 mcg (all differences not significant). Annualized relapse rates were lowest for 44 mcg (0.77) versus other groups (0.83-0.86, not significant). Persistent neutralizing antibodies did not affect relapse rates, but MRI active lesions were increased in antibody-positive patients receiving 44 mcg compared to antibody negative patients. CONCLUSIONS: In RRMS, once weekly IFN beta-1a, particularly 44 mcg, can induce a significant MRI, but not relapse, effect, compared with placebo. No significant dose effect was seen. In contrast to the significant effect observed with three-times-weekly dosing of subcutaneous IFN beta-1a compared with placebo, this study confirms the lack of meaningful clinical benefit with once-weekly dosing.

Adjuvants, Immunologic↗

PubMed1995

Treatment of louse-borne relapsing fever with low dose penicillin or tetracycline: a clinical trial.

A clinical trial was conducted in order to evaluate the efficacy of procaine penicillin and tetracycline, respectively, in the treatment of louse-borne relapsing fever. 184 patients (160 men, 24 women) admitted to the Gondar hospital during the rainy season 1992 were assigned to 1 of 4 treatment groups: procaine penicillin 100,000 (PP100), 200,000 (PP200) or 400,000 (PP400) international units (IU) intramuscularly (i.m.), or tetracycline 250 mg per os (TTC, p.o.). All drugs were given as single doses. The overall case fatality rate was 3.3%. Frequency of relapses, Jarisch-Herxheimer-like reactions (JHR) and deaths were significantly different between patients treated with TTC and those treated with PP100. Relapses occurred most often in the group receiving the lowest dose of penicillin (46%), and decreased with increasing dosage of penicillin; none of the patients treated with TTC had a relapse. Occurrence of JHR showed the opposite pattern: whilst 2 (5%) patients treated with PP100 developed a JHR, 16 (29%) in the PP200 group, 10 (31%) in the PP400 group, and 27 (47%) in the TTC group developed a JHR. As mortality is linked to severe JHR, and most relapses are clinically mild and easily treated, these results speak in favour of using low-dose penicillin to initiate the treatment of relapsing fever.

Adolescent↗

PubMed2003

Relapsing fever-like spirochetes infecting European vector tick of Lyme disease agent.

To determine whether relapsing fever-like spirochetes associated with hard ticks may infect Ixodes ricinus ticks in central Europe, we screened questing ticks for 16S rDNA similar to that of Asian and American relapsing fever-like spirochetes. We compared the prevalence of these spirochetes to that of Lyme disease spirochetes transmitted by the same vector. Relapsing fever-like spirochetes infect 3.5% of questing vector ticks in our three central European sites near the Rhein Valley. These spirochetes differ genetically from their American and Asian analogs while being relatively homogeneous in the region we sampled. The Lyme disease genospecies most commonly detected in central Europe are distributed broadly, whereas those that are less frequently found appear to be place-specific. The absence of co-infected ticks suggests that relapsing fever-like and Lyme disease spirochetes may not share hosts. Exposure risk for relapsing fever-like spirochetes is similar to that of certain Lyme disease genospecies. Although many persons may be bitten by ticks infected by relapsing fever-like spirochetes, health implications remain unknown.

Animals↗

PubMed2002

Relapsing fever in Gondar, Ethiopia.

OBJECTIVE: To determine the magnitude of relapsing fever, the rate of Jarisch-Herxheimer reaction (JHR) and its outcome and compare these parameters between adults and children in the same setting, time period and more or less similar management. DESIGN: A retrospective descriptive record analysis. SETTING: Gondar College of Medical Sciences (GCMS) hospital, paediatric ward and medical wards, northwest Ethiopia. SUBJECTS: Clinical records of 262 patients discharged with confirmed diagnosis of primary relapsing fever admitted between September 1995 and August 2000. RESULTS: Of the 13,177 patients admitted during the study period, 262 (1.99%) had a primary diagnosis of relapsing fever of which 70.6% were males. Children below 14 years of age comprised 41.2%. Of the total admissions, 83.6% were from Gondar town and the rest from outside. JHR was observed in 31.7% of the patients. The overall case fatality rate was 4.6%. Bad outcome was observed more frequently in adult patients. CONCLUSIONS AND RECOMMENDATIONS: Relapsing fever is still a public health problem. Because of the potential danger of the epidemic and its outcome it should not be neglected. Preventive programmes must be integrated with other services. Though the JHR is the most feared part of the management of relapsing fever, if health personnel are trained and competent, the management of relapsing fever can be delegated to the peripheral health workers, especially when it occurs in children. Moreover, the reason for bad outcome in adult patients than in children needs to be established.

Adolescent↗

PubMed2002

[Cutaneous vasculitis, myelodysplasia and relapsing polychondritis].

BACKGROUND: Relapsing polychondritis is a rare autoimmune disease, characterized by recurrent inflammation of cartilaginous tissues. In some cases, many other tissues can be involved. CASE REPORT: We describe the case of a 64 year-old man with relapsing polychondritis, whose first symptoms were papulonodular and mucosal aphthous lesions. The skin biopsy revealed vasculitis without leukocytoclasic features. The diagnostic of relapsing polychondritis was made only two years later, thanks to recurrent auricular chondritis. Since the beginning, the disease was associated with a myelodysplasia. DISCUSSION: Dermatological manifestations are noticed in less than 50 p. 100 of cases during the evolution of relapsing polychondritis. An association with a myelodysplasia has already been reported, and it could be a particular form of relapsing polychondritis. Myelodysplasic syndromes are more frequently associated with relapsing polychondritis than with other vasculitis. It must be sought especially when cutaneous and mucosal manifestations exist.

Humans↗

PubMed1991

Neonatal Borrelia infections (relapsing fever): report of 5 cases and review of the literature.

Tick borne relapsing fever is an endemic disease in Sengerema district, Mwanza region, Tanzania, East Africa. Five cases of neonatal relapsing fever occurring in this endemic area are described. Two neonates showed signs of septicaemia, clumping of spirochetes (Borrelia index is uncountable) in the thick blood smear and they died the day of admission. Two neonates showed severe spirochetaemia (Borrelia index: 3). The neonate treated with low dose penicillin died, the other neonate, treated with erythromycin, survived. One neonate had only a mild spirochetaemia (Borrelia index is 0.5) and responded well to penicillin treatment. Jaundice was seen in four of the five cases, three of them died. Only twenty cases of neonatal relapsing fever were previously reported. Findings are discussed in comparison with those of former reports on relapsing fever in the literature. Based on the fact that in a relatively short time (1 year), 5 cases of neonatal relapsing fever were diagnosed in an endemic area in East Africa, we conclude that neonatal relapsing fever is probably underdiagnosed.

Anti-Bacterial Agents↗

PubMed1987

Relapsing polychondritis syndrome associated with pustular psoriasis, spondylitis and arthritis mutilans.

We describe the first case of pustular psoriasis, HLA-B27 positive spondylitis, arthritis mutilans, and relapsing polychondritis. The relapsing polychondritis was mild and long undetected. Relapsing polychondritis is seen not uncommonly with a variety of inflammatory skin lesions. Because of this, and because many rheumatic diseases have been observed with relapsing polychondritis, we stress that relapsing polychondritis is a syndrome and not a unique disease. Relapsing polychondritis in mild form may be fairly common; a search for signs and symptoms of chondritis should be a routine part of the workup of patients with inflammatory rheumatic diseases and dermatoses.

Arthritis↗

PubMed1982

Relapse in major depressive disorder: analysis with the life table.

With the use of life tables to describe time while patients were well and subsequent rates of relapse for 75 patients after their recovery from an episodes of major depressive disorder in naturalistic study, a high risk of relapse was detected shortly after recovery. Twenty-four percent of patients relapsed within 12 weeks at risk, and 12% of patients relapsed with four weeks at risk. The presence of an underlying chronic depression and three or more previous affective episodes predicted a statistically significant increase in the rate of relapse. These data were used to develop an exponential model of relapse probability for a subgroup of the study population.

Actuarial Analysis↗

PubMed1982

Low serum neuroleptic levels predict relapse in schizophrenic patients.

Relapse occurs in a substantial proportion of schizophrenic patients treated with neuroleptics. The determinants of relapse have been elusive. In our study, low serum neuroleptic levels identified patients who had a relapse during a six-month period. Neuroleptic levels were measured by radioreceptor assay in 61 schizophrenic men and their clinical status was assessed in the subsequent six months. Ten patients had relapses, four showing a worsening of chronic psychotic symptoms and six showing eruption of psychotic symptoms after a period of remission. These ten patients had significantly lower normalized neuroleptic levels than those whose conditions remained stable. The lowest neuroleptic levels occurred in patients who had relapses after a period of remission. Serum neuroleptic levels in drug-responsive patients appear to be a critical determinant of remission. If these observations are replicated, a rational basis may be provided for prescribing and monitoring neuroleptic treatment and perhaps for preventing relapse.

Adult↗

PubMed1997

Positron emission tomography measurement of cerebral metabolic correlates of tryptophan depletion-induced depressive relapse.

BACKGROUND: Short-term depletion of plasma tryptophan has been shown to result in depressive relapse in patients with remission of major depression. Positron emission tomography and single photon emission computed tomography studies implicated the dorsolateral prefrontal cortex, orbitofrontal cortex, thalamus, and caudate nucleus in the pathogenesis of depression. The purpose of this study was to measure cerebral metabolic correlates of tryptophan depletion-induced depressive relapse. METHODS: Patients diagnosed as having major depression (N = 21) who clinically improved with serotonin reuptake inhibitors underwent 2 test days involving tryptophan depletion or placebo, followed 6 hours later by positron emission tomography scanning with fludeoxy-glucose F18. Brain metabolism was compared in patients with (n = 7) and without (n = 14) a tryptophan depletion-induced depressive relapse. RESULTS: Tryptophan depletion resulted in a decrease in brain metabolism in the middle frontal gyrus (dorsolateral prefrontal cortex), thalamus, and orbitofrontal cortex in patients with a depletion-induced depressive relapse (but not in patients without depletion-induced relapse). Decreased brain metabolism in these regions correlated with increased depressive symptoms. Baseline metabolism was increased in prefrontal and limbic regions in relapse-prone patients. CONCLUSION: Specific brain regions, including the middle frontal gyrus, thalamus, and orbitofrontal cortex, may mediate the symptoms of patients with major depression.

Antidepressive Agents↗